Sam Medical Products SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.

Recommended Action

Per FDA guidance

On 01/27/2022, the firm sent a "MEDICAL DEVICE RECALL" letter via signature required parcel service to distributors and direct internet customers informing them that the chest seal combo package may contain an occlusive dressing that has a hole in the center which would prevent the dressing from performing as an occlusive chest seal. Instructions to: For Distributors - 1. Indicate with a Yes or No response that you have received the SAM Chest Seal Combo Recall Notification (by signature required UPS delivery, email, fax or by phone) and understand the instructions from the Recall Notification. 2. Indicate with a Yes or No response if there have been any complaints or adverse events reported to you regarding the recalled product. If there was a report that a SAM Chest Seal Combo was not able to be used on a patient, please report the details on the Recall Response Form. 3. Affected Product Information - Information on the quantity of recalled devices shipped to your facility and the date the devices were shipped from SAM Medical is included on the Recall Response Form. - Quantity in Inventory Number of recalled SAM Chest Seal Combo products currently in your possession. - Quantity to Return This could be the same as the Quantity in Inventory but could include devices already returned from the sub-distributor or end user. - Quantity Used or Destroyed This is the number of recalled devices that have been used on patients, used in product demonstrations or in training events. - Quantity Further Distributed This is the number of recalled devices that you have sold to Sub-distributors and Direct Customers. 4. Distributor Information Place a mark the in the check box next to each of the statements that are applicable to you as a Distributor. 5. Complete the form by applying your Signature and the date the form was signed, print your name, company affiliation, phone number and email address. Return this Recall Response form to SAM Medical by Fax (503-

Distribution

As reported by FDA

AZ, CA, CO, FL, GA, MA, NY, OR, PA, RI, TX, VA, WA, PR